ASSUREPlus®

GUDID D6870083015FG2

ASSUREPlus® Self-Sealing Sterilization Pouch 7 x 13 (178mm x 330mm) Box of 200

Sultan Healthcare Inc

Sterilization packaging, single-use

• Primary Device ID: D6870083015FG2
• NIH Device Record Key: 9a4cda42-011a-43e8-95e1-b07a79335558
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSUREPlus®
• Version Model Number: 83015
• Company DUNS: 056296981
• Company Name: Sultan Healthcare Inc
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)989-8825
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6870083015FG2 [Package]; Contains: D687830151; Package: Case [12 Units]; In Commercial Distribution
HIBCC	D687830150 [Unit of Use]
HIBCC	D687830151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953829

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

On-Brand Devices [ASSUREPlus®]

• D6870083080FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 11 x 16 (279mm x 406mm) Box of 100
• D6870083075FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 5.25 x 7.5 (133mm x 191mm) Box of 200
• D6870083045FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 5.5 x 13 (140mm x 330mm) Box of 200
• D6870083025FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 12 x 18 (305mm x 457mm) Box of 100
• D6870083020FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 10 x 15 (254mm x 381mm) Box of 200
• D6870083015FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 7 x 13 (178mm x 330mm) Box of 200
• D6870083010FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 5.5 x 11 (140mm x 279mm) Box of 200
• D6870083005FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 3.5 x 10 (89mm x 254mm) Box of 200
• D6870083003FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 2.75 x 10 (70mm x 254mm) Box of 200
• D6870083001FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 2.25 x 4 (57mm x 102mm) Box of 200
• D6870083000FG2: ASSUREPlus® Self-Sealing Sterilization Pouch 3.25 x 6.5 (83mm x 165mm) Box of 200